FRESHFROZEN CELLS, HEP-2

K962782 · Diagnostic Hybrids, Inc. · KIR · Aug 29, 1996 · Hematology

Device Facts

• Record ID: K962782
• Device Name: FRESHFROZEN CELLS, HEP-2
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: KIR · Hematology
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.2280
• Device Class: Class 1

Indications for Use

Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus Parainfluenza HSV Poliovirus Coxsackie B RSV Measles

Device Story

FreshFrozen Cells™ (HEp-2 cell line) provided in frozen, measured quantities; user thaws and dilutes cells to prescribed volume; cells planted in containers to form confluent monolayers; used for virus isolation and identification in clinical samples; enables detection of Adenovirus, Parainfluenza, HSV, Poliovirus, Coxsackie B, RSV, and Measles; used by laboratory personnel.

Clinical Evidence

Bench testing only; product characterized by appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility.

Technological Characteristics

HEp-2 cell line; provided in frozen ampules; requires thawing and dilution; supports viral growth for isolation/identification; no electronic or software components.

Indications for Use

Indicated for use in clinical laboratories for the isolation and confirmation of Adenovirus, Parainfluenza, HSV, Poliovirus, Coxsackie B, RSV, and Measles from clinical samples.

Regulatory Classification

Identification

Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

Predicate Devices

• BioWhittaker cell cultures, Cryopreserved ampules

Submission Summary (Full Text)

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K962782

# AUG 29 1996

510(k) Summary

a.1. Diagnostic Hybrids, Inc.
1 President Street
Athens, OH 45701
[phone]
FAX: [phone]
Attn.: J.L. Brown
Date of Preparation: July 12, 1996

a.2. Trade Name: FreshFrozen Cells™
Classification Name: Cells, Animal and Human, Cultured.

a.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Cryopreserved ampules, Appendix II, p.19 of this 510(k) Notification.

a.4. The subject device provides frozen HEp-2 cells in measured quantities allowing the user to simply thaw and dilute the cells to a prescribed volume, plant prescribed volumes in appropriate containers and after a few days, the cell monolayers will be confluent and ready to use for virus isolation and identification.

a.5. Intended Use: Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:

Adenovirus
Parainfluenza
HSV
Poliovirus
Coxsackie B
RSV
Measles

a.6. A comparison of Technological Characteristics:

| Characteristics | Predicate Device | Subject Device |
| --- | --- | --- |
| Source of Cell Line | ATCC or another approved supplier. | Same as predicate device. |
| Provided Frozen | Cells can be stored frozen for months prior to thawing for use. | Same as predicate device. |
| Intended Use | Isolation & Confirmation of specific viruses. | Same as predicate device. |

b.1. The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.

b.2. Not Applicable.

b.3. Not Applicable.